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Fig. 3 | Trials

Fig. 3

From: Multicentre, double-blind, crossover trial to identify the Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM): study protocol for a randomised controlled trial

Fig. 3

Study assessment schedule (Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure). aThis visit is only required prior to randomisation, i.e. before starting the first treatment pathway. b Between scheduled study visits, the research nurse will contact the participant by telephone each week (a minimum of once per week). The nurse will confirm compliance with medication and remind the participant to complete study diaries/questionnaires. c Visits must normally be within ± 2 days of the scheduled visit date. Scheduled visit dates relate to the date of the previous visit. Where this is impossible, e.g. due to bank holidays or patient availability. d Week-8 visit only required for participants on combination treatment. e At the week-16 visit, participants will be given instructions to tape-off the current study treatment. Visits from week 0 to week 16 will be repeated until all 3 pathways have been completed. f Week 17 is only applicable following the final pathway. g FBC, urea and electrolytes, liver function tests, glycosylated haemoglobin A1c and serum creatinine. h hole blood sample to be collected and stored for future research. The sample can be obtained at the same time as any scheduled blood test for the study. Please refer to the OPTION-DM Sample Collection Manual for details. i Height (at week − 2 only), weight, heart rate and blood pressure (lying and standing). j To be completed by participants daily during the study, starting during the washout period. Pain scores may also be collected via daily text messages where participants have given additional consent for this. k Only required at week 0 of pathway 1, i.e. randomisation visit. l.Not required at week 0 of pathway 1, i.e. randomisation visit

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